Background

The concept of informed consent is based on both ethical and legal obligations that have evolved over the past century. The ethical foundations of informed consent are that the physician must strive to balance the goals of acting in the best interest of the patient while respecting the patient’s autonomy to decide what is best for his or her own body. Currently, informed consent requires an active role on the part of the patient, as well as respect for the patient’s wishes by the emergency physician (EP).¹

The legal foundation of informed consent centered initially on protection of the patient from battery or unwanted touching. In 1914, Justice Cardozo succinctly stated that “Every human being of adult years and sound mind has a right to determine what shall be done with his own body.”² The presumption is that every adult has the right to accept or decline recommended treatment from a physician.

When the patient is a minor, the general rule is that informed consent must be obtained from a parent before a physician may proceed with nonemergency treatment. However, EMTALA³ (Emergency Medical Treatment and Active Labor Act) permits a physician to evaluate every patient, including minors, to assess whether an emergency medical condition exists and to stabilize any such condition.⁴ Many exceptions exist to the general rule of parents consenting for their minor children. For example, a minor may have the ability to consent to treatment of sexually transmitted diseases or drug addiction. These exceptions vary from state to state, however, so it is important to be familiar with the local laws where you practice.

Today, in the absence of a recognized exception to the requirement for informed consent, failure to obtain consent properly may also result in liability under the legal theories of privacy or negligence. In the emergency department (ED), we often find ourselves in circumstances in which the so-called emergency exception applies. The emergency exception states that consent is implied in cases in which an immediate threat to the life or health of the patient exists, when the proposed treatment is necessary to address the emergency condition, and when one is unable to obtain express consent of the patient or someone authorized to consent on the patient’s behalf. In these instances the EP may presume that the patient would consent to the emergency treatment, and the EP does not need to obtain express consent before proceeding with treatment.⁵

Elements

To satisfy the requirements of informed consent, three elements must be met. First, the physician must provide the patient with adequate disclosure of information to enable the patient to make an informed decision. Second, the patient must make the decision voluntarily. Finally, the patient must have the capacity to make the decision.

The scope of information to be disclosed is well established in theory but challenging in practice. The physician must disclose (1) the nature of the disease or problem and the nature and purpose of the proposed treatment or procedure; (2) the potential benefits and risks associated with the proposed treatment or procedure, as well as the likelihood that they will occur; and (3) alternative approaches, as well as the benefits and risks of such alternatives.⁶

Fulfillment of the disclosure element in the ED poses several challenges. For example, the time for patient-physician interaction is often limited in the ED. In addition, a quiet and private setting for discussion is often unavailable. Furthermore, the EP is typically working with limited knowledge about the full scope of the patient’s medical history, intellectual capabilities, and emotional state.⁷ It is the EP’s responsibility, however, to minimize the impact of these challenges and to provide information that will maximize the likelihood that the patient will participate effectively in the decision-making process.

The second element, that consent must be given voluntarily, is not as well delineated in the medical literature or by the courts. Although it is obvious that outright threats or forced treatments violate this tenet, there are subtle ways in which a physician may coerce a patient into making a decision that are also unacceptable. For example, if a physician tells a patient that pain medicine will be withheld until the patient agrees to undergo a computed tomography (CT) scan, the voluntary nature of the patient’s decision will be compromised. Additionally, the physician cannot withhold or distort information to alter a patient’s decision. The physician must present information in a way that aids the patient in making the decision and leaves the patient feeling that he or she has an actual choice in the matter.

The final element—and the focus of the remainder of this chapter—is that the patient must possess decision-making capacity. Decision-making capacity refers to a patient’s ability to participate in and make a meaningful decision regarding diagnosis and treatment. The treating physician must determine whether the patient is able to make a specific decision regarding his or her medical care. However, the physician must start with the presumption that an adult patient has the capacity to give informed consent and, absent evidence to the contrary, health care decisions should be deferred to the patient. If the physician determines that the patient lacks the capacity to make medical decisions, the physician must then determine how to proceed. If the patient has specifically expressed health care wishes through an advanced directive, these wishes should be honored. Similarly, if the patient has designated an individual to make health care decisions for him or her, that person should be contacted to make decisions on behalf of the patient. In other instances, family members should be contacted to help make health care decisions.

Although psychiatric consultation may be helpful in assessing decisional capacity in patients, it is not required. Formal legal procedures also exist to assist in the determination, but evaluations of capacity are routinely made without recourse to the court system. The process is usually performed solely by the treating EP in the ED. Indeed, the EP assesses decision-making capacity as part of routine interactions with every patient treated.